510(k) K122537 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0
| Applicant | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical, Wallingford CT, US |
| Decision | Substantially Equivalent, Apr 12, 2013 |
| Received | Aug 20, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122537
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.